Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1222-2015·Announced 2015-07-15

American Health Packaging Recalls Azithromycin Tablets Due to Complaint Investigation Failures

American Health Packaging is recalling 838 cartons of Azithromycin 600mg tablets because the firm did not adequately investigate customer complaints.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a CGMP deviation regarding complaint investigation without reported illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

American Health Packaging is voluntarily recalling 838 cartons of Azithromycin tablets, USP 600mg. The product is packaged in 10-count blisters (NDC 68084-464-11) with 3 blister packs per carton (NDC 68084-464-21). The tablets are prescription-only and were manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt, USA, LLC in Parsippany, NJ.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The affected lots are 134420 and 142540, with an expiration date of 7/31/2015. The product was distributed nationwide.

Consumers and healthcare providers with this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal. No specific illnesses or injuries are reported in the source text.

The recalled product

Product: Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Manufacturer: American Health Packaging
Category: Drug — Antibiotic
Hazard: cgmp-deviation
complaint-investigation
Affected units: 838

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot#: 134420
142540
Exp 7/31/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by American Health Packaging under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Same manufacturer · American Health Packaging

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